InfluenzaPhase 1/2NCT02572583
A Clinical Study of Treating Influenza With Liugan Shuangjie Heji
A Phase 1/2 study testing Liugan Shuangjie Heji, Shufeng Jiedu Capsule and Oseltamivir Phosphate Capsule in people with Influenza, run by Dongfang Hospital Beijing University of Chinese Medicine at 1 site in China.
Trial summary
This prospective randomized controlled trial studies the efficacy and safety of treating influenza with the reconciling exterior and interior therapy. A total of 300 cases of seasonal flu in Beijing is to be collected, and divided into one treatment group and two control groups. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Influenza
- What is being tested?
- Liugan Shuangjie Heji, Shufeng Jiedu Capsule and Oseltamivir Phosphate Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Nov 2014to Nov 2016
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The disease in flu season of flu, in line with the western medicine clinical diagnostic criteria for influenza;
- All influenza patients with TCM syndrome differentiation for the table is cold in the exterior and heat in the interior;
- The course of the disease within 48 hours, the axillary temperature is 38.0 degree or higher;
- Aged between 18 to 65 years;
- Voluntary and signed informed consent.
Who cannot join
- The first time to see a doctor Have used traditional Chinese medicine, or antiviral drugs;
- Routine blood WBC is greater than the upper limit of normal;
- Chest X-ray examination with inflammatory exudation images;
- With cardiovascular, liver, kidney and hematopoietic system such as severe primary disease, immunodeficiency disease, cancer, mental illness, without self-knowledge, liver and kidney function significantly abnormal liver meritorious service is more than 1.5 times higher than normal;
- Pregnancy, nursing mothers, and allergic constitution;
- Participated in clinical subjects for nearly three months.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Dongfang Hospital affiliated to Beijing University of Chinese Medicine
Beijing, 100078
Yang Jiao, MD, +86 13601016612, Yangjiao2013@sina.cn
About this study
This prospective randomized controlled trial studies the efficacy and safety of treating influenza with the reconciling exterior and interior therapy. A total of 300 cases of seasonal flu in Beijing is to be collected, and divided into one treatment group and two control groups. Patients in the treatment group will receive Liugan Shuangjie Heji, while patients in control groups will receive Shufeng Jiedu Capsule and Oseltamivir Phosphate Capsule respectively, for a course of 5 days. The study assesses the efficacy and safety of treating influenza with the reconciling therapy based on the following outcome measures: the time it takes from the medicine intake to 0.5℃ drop of body temperature, and the time it takes for the body temperature to return to normal.
- Conditions
- Influenza
- Being tested
- Liugan Shuangjie Heji, Shufeng Jiedu Capsule, Oseltamivir Phosphate Capsule
- Keywords
- Reconciling Exterior and Interior Therapy, Influenza
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liugan Shuangjie HejiDrug
Shufeng Jiedu CapsuleDrug
Oseltamivir Phosphate CapsuleDrug
| Study group | Role | What they receive |
|---|---|---|
| Liugan Shuangjie Heji Group | Experimental | Liugan Shuangjie Heji, take orally, 4 times a day, 100 ml each time (i.e. two doses per day), for a course of five days. Receives: Drug: Liugan Shuangjie Heji |
| Shufeng Jiedu Capsule Group | Active comparator | Shufeng Jiedu Capsule, take orally, 3 times a day, 4 capsules each time, for a course of five days. Receives: Drug: Shufeng Jiedu Capsule |
| Oseltamivir Phosphate Capsule Group | Active comparator | Oseltamivir Phosphate Capsule, take orally, 2 times a day, 75 mg each time, for a course of five days. Receives: Drug: Oseltamivir Phosphate Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
time from the medicine intake to 0.5℃ drop of body temperature
Measured: five days
time for the body temperature to return to normal
Measured: five days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2015 (estimated)
- Study startNov 2014
- Primary completionNov 2016 (estimated)
- Study completionNov 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dongfang Hospital Beijing University of Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yang - Jiao, MD, Study director, Dongfang Hospital Beijing University of Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02572583
- Sponsor's protocol ID
- 2013BAI13B021
- Status last verified
- Apr 2015
- First submitted
- 12 Apr 2015
- Last updated
- 9 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study of Treating Influenza With Liugan Shuangjie Heji
- ClinicalTrials.gov ID
- NCT02572583
- Acronym / sponsor ID
- 2013BAI13B021
- Conditions
- Influenza
- Keywords
- Reconciling Exterior and Interior Therapy, Influenza
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Dongfang Hospital Beijing University of Chinese MedicineUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Nov 2016 (estimated)
- First posted
- 9 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective randomized controlled trial studies the efficacy and safety of treating influenza with the reconciling exterior and interior therapy. A total of 300 cases of seasonal flu in Beijing is to be collected, and divided into one treatment group and two control groups. Patients in the treatment group will receive Liugan Shuangjie Heji, while patients in control groups will receive Shufeng Jiedu Capsule and Oseltamivir Phosphate Capsule respectively, for a course of 5 days. The study assesses the efficacy and safety of treating influenza with the reconciling therapy based on the following outcome measures: the time it takes from the medicine intake to 0.5℃ drop of body temperature, and the time it takes for the body temperature to return to normal.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Liugan Shuangjie Heji Group | Experimental | Drug: Liugan Shuangjie HejiLiugan Shuangjie Heji, take orally, 4 times a day, 100 ml each time (i.e. two doses per day), for a course of five days. |
| Shufeng Jiedu Capsule Group | Active comparator | Drug: Shufeng Jiedu CapsuleShufeng Jiedu Capsule, take orally, 3 times a day, 4 capsules each time, for a course of five days. |
| Oseltamivir Phosphate Capsule Group | Active comparator | Drug: Oseltamivir Phosphate CapsuleOseltamivir Phosphate Capsule, take orally, 2 times a day, 75 mg each time, for a course of five days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The disease in flu season of flu, in line with the western medicine clinical diagnostic criteria for influenza;
- All influenza patients with TCM syndrome differentiation for the table is cold in the exterior and heat in the interior;
- The course of the disease within 48 hours, the axillary temperature is 38.0 degree or higher;
- Aged between 18 to 65 years;
- Voluntary and signed informed consent.
Key exclusion criteria (6 listed)
- The first time to see a doctor Have used traditional Chinese medicine, or antiviral drugs;
- Routine blood WBC is greater than the upper limit of normal;
- Chest X-ray examination with inflammatory exudation images;
- With cardiovascular, liver, kidney and hematopoietic system such as severe primary disease, immunodeficiency disease, cancer, mental illness, without self-knowledge, liver and kidney function significantly abnormal liver meritorious service is more than 1.5 times higher than normal;
- Pregnancy, nursing mothers, and allergic constitution;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liugan Shuangjie Heji | Drug | Liugan Shuangjie Heji Group |
| Shufeng Jiedu Capsule | Drug | Shufeng Jiedu Capsule Group |
| Oseltamivir Phosphate Capsule | Drug | Oseltamivir Phosphate Capsule Group |
Primary outcome
time from the medicine intake to 0.5℃ drop of body temperature
Time frame: five days
time for the body temperature to return to normal
Time frame: five days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yang - Jiao, MD study director
Dongfang Hospital Beijing University of Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Liugan Shuangjie Heji, Shufeng Jiedu Capsule and Oseltamivir Phosphate Capsule in people with Influenza, run by Dongfang Hospital Beijing University of Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yang - Jiao, MD (+86 13601016612, Yangjiao2013@sina.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time from the medicine intake to 0.5℃ drop of body temperature (time frame: five days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2015.